A growing number of U.S. hospitals are saving money by reusing medical devices designated for one-time use, ignoring the warnings of manufacturers...
WASHINGTON — A growing number of U.S. hospitals are saving money by reusing medical devices designated for one-time use, ignoring the warnings of manufacturers, which will not vouch for the safety of reconditioned products.
Hospitals are not required to tell patients that reconditioned devices will be used in surgery. Surgeons themselves often do not know. The Food and Drug Administration regulates the practice, and many hospital administrators say reusing single-use devices is not only cost-effective but promotes healthy competition with device makers and poses no threat to patients because the instruments are carefully cleaned.
But single-use devices have malfunctioned during reuse, federal records and interviews show.
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In one instance, an electrode from a catheter broke off in a patient’s heart. In another, a patient’s eyeball was impaled. And an infant who for months gagged and retched on a resterilized tracheal tube now can take food only from a tube attached to his stomach.
Based on available data, it is impossible to compare how often single-use devices malfunction in their first operation versus subsequent uses. That is because the FDA, which devotes few resources to overseeing what is now a fast-growing industry, began requiring only last year that hospitals report whether a malfunctioning device had been reprocessed.
The Washington Post examined thousands of pages of documents, including FDA records, court filings and internal company reports, and was able to document dozens of cases of patient injuries and device malfunctions after single-use devices were reused.
In one case in March 1998, cardiologist Peter Karpawich removed a single-use catheter from a child’s body. The tip of the device appeared to be twisted, and the shaft at one end had separated from its bonding.
After investigating, manufacturer Boston Scientific Corp. told the FDA that the problems were “likely due to aggressive disinfecting and cleaning between uses.”
Although the patient was fine, Karpawich said, Children’s Hospital of Michigan in Detroit immediately stopped all reprocessing of single-use devices.
“If there is the remotest possibility that a catheter might be used twice, that you could potentially harm a patient, you should not use it,” he said. “It’s common sense.”
Nonetheless, single-use devices are being manufactured and reused with increasing frequency. New plastics and other materials make it possible for companies to build intricate — and sometimes delicate — specialized devices that many doctors say are particularly effective in treating patients.
The FDA allows manufacturers to choose between getting approval for a device to be used once or multiple times. Companies are frequently choosing one-time use, which means their products do not have to be as sturdy, their liability is diminished after the first use and they are ensured a steady stream of replacement orders.
The manufacturers often ship the devices sealed individually in sterile packaging, marked with warnings that they are not to be reused.
At the same time, hospitals are increasingly disregarding the one-time-only designation as a manufacturer’s ploy to force them to buy more devices than they need.
While some hospitals clean and resterilize devices in-house, others send their used devices to outside companies. The three biggest U.S. reprocessors declined to disclose the hospitals they serve but said they have 3,370 accounts and last year refurbished about 4.6 million single-use devices.
Reprocessors often need to take apart the medical instruments — many involving small openings and delicate attachments — to figure out how they can be cleaned. While device makers question such practices, the American Hospital Association supports the practice, noting the FDA’s oversight and the cost savings for hospitals. For example, new biopsy forceps can cost $60; reused ones cost as little as $15.
Device makers say the single-use tag is not just a label.
“Single-use devices typically contain difficult-to-access areas that create barriers to cleaning and permit blood, tissue or other bodily fluids to contaminate the reprocessed device, allowing potential transmission of viral and bacterial infections,” said Stephen Ubl, president and chief executive of the Advanced Medical Technology Association, which represents device makers.
But an association that represents reprocessors said there is “no credible evidence” that refurbished single-use devices are riskier than new ones.
Caught in the middle of the debate are patients and their families.
Susan and Tony Van Duyn think patients should be told when single-use devices are being reused.
Their son, Sean, 5, lives in his own world. For hours each day, he sits on his knees inches from a television, his head tilted to the left, hazel eyes blank, mouth agape, bouncing up and down, clapping to a children’s video, “Blue’s Clues.” It is the only thing he will watch on television.
He cannot take food or drink by mouth, which his family’s lawyer says is the result of a failed reprocessed medical device.
The hospital and doctors involved in Sean’s treatment settled a lawsuit with the family, so no court determined the facts of their case.
Days after his birth in 2000, Sean was rushed to Arnold Palmer Hospital for Children & Women in Orlando because of a brain inflammation. He suffered neurological damage.
During surgery, doctors inserted a tube in Sean’s throat to help him breathe. But the tube was too big and caused an injury to the lining of his airway, the family said in its lawsuit.
That required a tracheotomy — cutting a hole in Sean’s throat below his Adam’s apple — in January 2001. A plastic tube was inserted in his throat so he could breathe. Through its in-house sterilization department, hospital records show, the medical facility reprocessed the tracheal tube despite an explicit warning on the packaging from the manufacturer that the device was not to be resterilized.
The hospital does not dispute that it resterilized the device, said its attorney, Richards Ford. Two reprocessed tubes were used in Sean’s throat for nine months, while he vomited and retched several times a day. The Van Duyns said they repeatedly asked their doctors whether Sean was having a bad reaction to the tubes and whether they should use a new one. They said the doctors told them that Sean was vomiting and retching because of his neurological problems.
Finally, in September 2001, Sean’s mother decided on her own to give him a new tracheal tube. She said his retching stopped immediately. But by then, Sean had suffered permanent damage.
The big three reprocessors say they perform a great service for hospitals, noting that they reduced hospital waste by 935 tons in 2004, the first year such numbers were tabulated.
Aside from reducing waste and saving money, reprocessors stress that they follow strict cleaning and sterilization procedures and say they test every device they recondition. They also note that Congress’ investigative arm, the Government Accountability Office, “found little available evidence of harm from reuse” when it looked into the matter in 2000. The GAO also said that “reprocessing is not invariably safe.”
The big three said they are paid per device reprocessed. If they are not able to recondition a single-use device, they say, they will absorb the cost.
Their business, they say, depends on their reputation for safe reprocessing.